Engage the “patient voice” by establishing partnerships from the beginning of the research and development program to improve trial design and execution

Clearly define the expectations, roles, and responsibilities of all partners, including the resources being committed, data being shared, and objectives of the program

Manage real or perceived conflicts of interest by establishing policies that require full disclosure, transparency, and accountability

The PEAC is composed of patients and caregivers who provide perspective to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. This first meeting brought together patients, patient organizations, FDA, industry, and other medical and scientific experts for discussion on incorporating patient perspectives in the design, conduct, and reporting of medical device clinical trials.

Meeting materials, including slide presentations, are available on the FDA website.

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